BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTDRIVE

    MDR report key: 18519317 · Received January 16, 2024

    Report

    Report Number
    3008370857-2024-00002
    Event Type
    Injury
    Date Received
    January 16, 2024
    Date of Event
    October 1, 2023
    Report Date
    January 16, 2024
    Manufacturer
    MAX MOBILITY LLC
    Product Code
    ITI
    UDI-DI
    00861896000310
    PMA / PMN Number
    K151199
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE END-USER REPORTS HAVING DIFFICULTY GETTING THE SMARTDRIVE UNIT TO DISENGAGE THE DRIVE MOTOR WHEN GIVING A TAPPING MOTION. REPORTS THE DAY OF EVENT, THEY HAD GIVEN THEIR APPLE 4 WATCH A DOUBLE TAP AND THE DEVICE REPORTEDLY FAILED TO STOP WHICH FORCED THEM TO IMPACT A DESK AND THIS REPORTEDLY LED TO A LACERATION ON THEIR CALF REQUIRING STICHES. THE END-USER EXCLAIMED THIS EVENT OCCURRED IN OCTOBER OF 2023, BUT COULD NOT GIVE A DEFINITIVE DATE. END-USER REPORTS THEY DID NOT THINK TO REPORT AT THE TIME AS THEY RARELY USE A WEARABLE DEVICE FOR CONTROL, PREFERRING TO USE A WIRED OPTION. REPORTER CLAIMS THE APPLE WATCH REMAINS FUNCTIONAL AND THEY FEEL IT MAY HAVE TO DO WITH THE RATE AT WHICH THEY TAPPED. PERMOBIL CUSTOMER SERVICE INSTRUCTED THE END-USER ON HOW TO ADJUST THE SENSITIVITY FOR THE CONTROL DEVICE TO MEET THE CLIENTS' PHYSICAL NEEDS. AS THE DEVICE AND APPLE WATCH ARE REPORTEDLY OPERATING NORMALLY, PERMOBIL CANNOT REACH A DETERMINATION AS TO PROBABLE ROOT CAUSE WITHOUT SPECULATION. THE DHR WAS REVIEWED, AND THE DEVICE WAS FOUND TO HAVE MET SPECIFICATIONS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 0

    REPORTS WHILE OPERATING THE SMARTDRIVE MX2+ UNDER POWER, THE END-USER ATTEMPTED TO DISENGAGE DRIVE VIA A TAPPING MOTION OF THE APPLE 4 WATCH BUT REPORTEDLY FAILED TO RECOGNIZE THE COMMAND AND CONTINUED TO DRIVE, FORCING THE END-USER TO IMPACT A DESK RESULTING IN AN INJURY REQUIRING MEDICAL INTERVENTION TO ADDRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712614 SMARTDRIVE SMARTDRIVE ITI MAX MOBILITY LLC MX2+ N/A 00861896000310

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention